Director, Quality Systems Management (Darby) Job

Avantor
Director, Quality Systems Management (Darby) Job

Full-Time Executive Management Job

The Director, Quality Systems Management is the global leader of the functions creating and owning policies, processes, and procedures for all subsystems (e.g. CAPA, Manufacturing Controls, Design and Development Control, Risk Management, Document Control, etc.) of the Quality Management System. The Director, Quality Systems Management is responsible for setting Avantors Quality System strategy for all aspects of the business. In addition, the Director is responsible for the creation and ownership of all Quality System policies, processes, and procedures, and for sustaining a center of excellence compliant to regulations, standards, and guidelines governing Quality System activities for medical device, pharmaceutical, and biological products.

Monitor department processes and workflow for opportunities for improvement and optimization.

Drive Operational Excellence programs across the department and across the Avantor network.

Monitor changes in regulations, standards, and guidance, and provide recommendations, and implementation plans for adherence to new or changing requirements.

Ensure timely integration of Quality System policies, processes, and procedures for acquired or newly launched products.

Ensure that all team members receive appropriate and timely training.

Communicate across all applicable Avantor businesses to ensure Quality System metrics are clearly visible and operations are maintained within a state of control.

Direct management and teams to continually evaluate current policies, procedures and practices to develop and implement improvements.

Represent the Quality Management System during internal/external audits and inspections. Serves as company representative to various US and international regulatory bodies (regulatory authorities and notified bodies). Interacts directly with designated points of contact.

Monitor work flow to ensure quantity and quality are consistently met. Continually initiate plans to maximize use of resources, and/or take corrective action to resolve problems to accomplish department tasks and goals.

Conduct management activities such as interviewing/hiring new employees, processing time records and PTO requests, producing and administering performance evaluations, and any employee disciplinary actions.

Assess and define department training needs. Confirm all training needs are met, and training is completed within the expected timeframes.

EDUCATION AND EXPERIENCE

Bachelors degree or equivalent in a Life Science, Engineering, or Physical Sciences area of study.

Ability to review, analyze, summarize, and interpret data draw conclusions and make recommendations and decisions, write reports, and give oral presentations tailored to the receiving audience.

Sense of urgency and intellectual curiosity.

Demonstrated continuous improvement philosophy.

DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

EEO Statement

We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at ...@avantorinc.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about our commitment to equal employment opportunity, please Privacy Policy(Links to (1) EEO is the Law poster and any supplements, (2) pay transparency nondiscrimination statement, and (3) if desired, Company EEO/AA Statement